MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles
FLEX
1 other identifier
observational
30,000
4 countries
134
Brief Summary
The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Longer than P75 for all trials
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedStudy Start
First participant enrolled
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2037
August 20, 2025
August 1, 2025
19.9 years
February 9, 2017
August 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.
10 years
A shared registry infrastructure to examine smaller groups of interest.
Create a shared registry infrastructure to examine smaller groups of interest.
10 years
Secondary Outcomes (1)
Subset analyses based on full genome data will be created.
10 years
Study Arms (1)
MammaPrint and BluePrint testing
All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines.
Interventions
Agendia will run MammaPrint and BluePrint tests using the full genome testing array.
Eligibility Criteria
Study population will include patients with stage I, II, or III breast cancer that have signed an informed consent, and are eligible to receive chemotherapy and endocrine therapy. Patients will be excluded if they have metastatic disease or do not have ample tissue to send to Agendia for testing.
You may qualify if:
- Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
- Informed consent form signed on the same day or before enrollment
- New primary lesion
You may not qualify if:
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Metastatic disease
- Recurrent disease
- Stage 0 disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agendialead
Study Sites (134)
CHS Grandview
Birmingham, Alabama, 35243, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Arizona Oncology Associates, PC
Phoenix, Arizona, 85006, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704, United States
Adventist Health - Bakersfield
Bakersfield, California, 93301, United States
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262, United States
North Valley Breast Clinic
Redding, California, 96001, United States
UCSF Breast Care Center
San Francisco, California, 94158, United States
Valley Breast Care
Van Nuys, California, 91405, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Comprehensive Breast Care of Denver
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Center - Lakewood
Lakewood, Colorado, 80228, United States
Vail Health - Shaw Cancer Center
Vail, Colorado, 81658, United States
St. Mary's Hospital
Waterbury, Connecticut, 06706, United States
Medical Oncology and Hematology Consultants
Newark, Delaware, 19713, United States
Breast Specialists of South Florida
Atlantis, Florida, 33462, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33428, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Halifax Health - Center for Oncology
Daytona Beach, Florida, 32114, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
University of Florida - Jacksonville
Jacksonville, Florida, 32224, United States
St. Vincent Hospital / Mayo Clinic
Jacksonville, Florida, 32256, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Sylvester Comprehensive Cancer Center - University of Miami
Miami, Florida, 33136, United States
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, 33176, United States
Cancer Care Centers of Brevard
Rockledge, Florida, 32955, United States
St. Joseph's Hospital - Baycare
Tampa, Florida, 33607, United States
University of South Florida
Tampa, Florida, 33613, United States
Winter Haven Hospital
Winter Haven, Florida, 33881, United States
Phoebe Health
Albany, Georgia, 31701, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Southeast Georgia Health System - Physician Associates
Brunswick, Georgia, 31520, United States
DeKalb Medical Center
Decatur, Georgia, 30033, United States
Candler Hospital
Savannah, Georgia, 31405, United States
Tift Regional Health System
Tifton, Georgia, 31794, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Saint Alexius Medical Center
Hoffman Estates, Illinois, 60169, United States
Affiliated Oncologists
Oak Lawn, Illinois, 60453, United States
Parkview Health
Fort Wayne, Indiana, 46805, United States
Louisiana State University
Shreveport, Louisiana, 71103, United States
Northern Light Breast Care
Portland, Maine, 04102, United States
Luminis Health Center for Cancer & Blood Disorders
Annapolis, Maryland, 21401, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
Maryland Oncology Hematology - Bethesda
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology - Brandywine
Brandywine, Maryland, 20613, United States
Maryland Oncology Hematology - Clinton
Clinton, Maryland, 20735, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044, United States
UPMC at Western Maryland Health System
Cumberland, Maryland, 21502, United States
Frederick Oncology Hematology Associates
Frederick, Maryland, 21702, United States
Maryland Oncology Hematology - Aquilino Cancer Center
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology, PA
Silver Spring, Maryland, 20904, United States
Mercy Medical Center
Springfield, Massachusetts, 01104, United States
St. John Hospital
Grosse Pointe Woods, Michigan, 48236, United States
Sparrow Cancer Center
Lansing, Michigan, 48912, United States
Beaumont Breast Care Center
Royal Oak, Michigan, 48076, United States
Providence - Providence Park Hospital
Southfield, Michigan, 48075, United States
Comprehensive Breast Care
Troy, Michigan, 48098, United States
Minnesota Oncology
Minneapolis, Minnesota, 55404, United States
Boone Hospital Center
Columbia, Missouri, 65201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
New York Oncology Hematology
Albany, New York, 12206, United States
Broome Oncology
Binghamton, New York, 13905, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Lake Success Oncology / ProHealth Care
Lake Success, New York, 11020, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
Northwell Health- Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Kings County Hospital
New York, New York, 10004, United States
Hematology Oncology Center of Rockland at Nyack
Nyack, New York, 10960, United States
University of Rochester - Pluta Cancer Center
Rochester, New York, 14642, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Northwell Health- Phelps Hospital
Tarrytown, New York, 10591, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
TriHealth Cancer Institutes
Cincinnati, Ohio, 45220, United States
Oncology Hematology Care
Cincinnati, Ohio, 45236, United States
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, 73505, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, 15213, United States
Grandview Hospital
Sellersville, Pennsylvania, 18960, United States
Roper St. Francis Physician Partners - Breast Surgery
Charleston, South Carolina, 29401, United States
Tidelands Health Coastal Carolina Breast Center
Georgetown, South Carolina, 29442, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
Nashville Breast Center
Nashville, Tennessee, 37203, United States
Texas Oncology - Allen
Allen, Texas, 75013, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Texas Oncology - Austin
Austin, Texas, 78731, United States
Texas Oncology - Bedford
Bedford, Texas, 76022, United States
Texas Oncology - Carrollton
Carrollton, Texas, 75010, United States
CHRISTUS Spohn Cancer Center
Corpus Christi, Texas, 78404, United States
Texas Oncology - Methodist Dallas Cancer Center
Dallas, Texas, 75203, United States
Texas Oncology - Presbyterian
Dallas, Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Denton
Denton, Texas, 76210, United States
Texas Oncology - Flower Mound
Flower Mound, Texas, 75028, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Texas Oncology - Grapevine
Grapevine, Texas, 76051, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
Texas Oncology Willowbrook
Houston, Texas, 77070, United States
Oncology Consultants
Katy, Texas, 77494, United States
University of Texas Medical Branch
League City, Texas, 77573, United States
Texas Oncology - Longview
Longview, Texas, 75601, United States
Texas Tech UHSC - Southwest Cancer Center
Lubbock, Texas, 79430, United States
Texas Oncology - McKinney
McKinney, Texas, 75071, United States
Texas Oncology - Plano East
Plano, Texas, 75075, United States
Texas Oncology - Plano West
Plano, Texas, 95093, United States
Texas Oncology, PA - Metropolitan
San Antonio, Texas, 78212, United States
Texas Oncology, PA - Northeast
San Antonio, Texas, 78217, United States
UT Health Cancer Center
San Antonio, Texas, 78229, United States
Texas Oncology PA -San Antonio Medical Center
San Antonio, Texas, 78240, United States
Texas Oncology, PA - Stone Oak
San Antonio, Texas, 78258, United States
Texas Oncology - Sugar Land
Sugar Land, Texas, 77479, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Texas Oncology - Waco
Waco, Texas, 76712, United States
Texas Oncology - Webster
Webster, Texas, 77584, United States
Ogden Regional Cancer Center
Ogden, Utah, 84405, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98273, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Columbia St. Mary's
Milwaukee, Wisconsin, 53211, United States
William Osler Cancer Centre
Brampton, Ontario, L6R 3J7, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
University General Hospital Alexandra
Athens, Greece
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Related Publications (1)
Brufsky AM, Hoskins KF, Conter HJ, Kelemen P, Habibi M, Samian L, Rahman RL, Lee L, Dias EC, Hampton R, Sieling BA, Osborne CR, Brown E, Elayoubi JA, Sharma P, Ramadurai J, Matt-Amaral L, Santillan AA, Davis S, Albaneze P, Ramaswamy H, Chmielewski-Stivers N, Menicucci A, Audeh W, Whitworth P, Johnson N, O'Shaughnessy J. MammaPrint predicts chemotherapy benefit in HR+HER2- early breast cancer: FLEX Registry real-world data. JNCI Cancer Spectr. 2025 Sep 1;9(5):pkaf079. doi: 10.1093/jncics/pkaf079.
PMID: 40796181DERIVED
Biospecimen
Tumor tissue acquired as part of a standard of care biopsy or surgical procedure will be sent to Agendia for testing.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Audeh, MD
Agendia, Inc.
- PRINCIPAL INVESTIGATOR
Joyce O'Shaughnessy, MD
Texas Oncology - Baylor Charles A. Sammons Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 15, 2017
Study Start
April 28, 2017
Primary Completion (Estimated)
April 1, 2037
Study Completion (Estimated)
December 1, 2037
Last Updated
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share